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A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

Primary Purpose

Type 1 Diabetes

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Harmony 1 Sensor
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is 14 - 75 years of age at time of screening
  2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
  3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

  1. Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual.
  2. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
  3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
  4. Subject is female and has a positive pregnancy screening test
  5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
  6. Subject is female and plans to become pregnant during the course of the study
  7. Subject has had a hypoglycemic seizure within the past 6 months
  8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit.
  9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
  10. Subject has a history of a seizure disorder
  11. Subject has central nervous system or cardiac disorder resulting in syncope
  12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
  13. Subject has a hematocrit (Hct) lower than the normal reference range
  14. Subject has a history of adrenal insufficiency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Harmony 1 Sensor Group A

    Harmony 1 Sensor Group B

    Arm Description

    Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion.

    Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion.

    Outcomes

    Primary Outcome Measures

    24 hour calibration requirement
    Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2015
    Last Updated
    November 16, 2017
    Sponsor
    Medtronic Diabetes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02646878
    Brief Title
    A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
    Official Title
    A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision
    Study Start Date
    January 2016 (Anticipated)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Diabetes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
    Detailed Description
    The study is a multi-center, prospective single-sample correlational design without controls.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Harmony 1 Sensor Group A
    Arm Type
    Other
    Arm Description
    Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion.
    Arm Title
    Harmony 1 Sensor Group B
    Arm Type
    Other
    Arm Description
    Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion.
    Intervention Type
    Device
    Intervention Name(s)
    Harmony 1 Sensor
    Intervention Description
    Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.
    Primary Outcome Measure Information:
    Title
    24 hour calibration requirement
    Description
    Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is 14 - 75 years of age at time of screening A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Adequate venous access as assessed by investigator or appropriate staff Exclusion Criteria: Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks Subject is female and has a positive pregnancy screening test Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator Subject is female and plans to become pregnant during the course of the study Subject has had a hypoglycemic seizure within the past 6 months Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit. Subject has a history of a seizure disorder Subject has central nervous system or cardiac disorder resulting in syncope Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease Subject has a hematocrit (Hct) lower than the normal reference range Subject has a history of adrenal insufficiency.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Brazg, MD
    Organizational Affiliation
    Rainer Clinical Research Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mark Christiansen, MD
    Organizational Affiliation
    Diablo Clinical Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

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